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Trial record 29 of 538 for:    "Skin cancer"

The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention

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ClinicalTrials.gov Identifier: NCT00709306
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : February 22, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carolyn Heckman, Fox Chase Cancer Center

Brief Summary:
The purpose of the proposed project is to investigate the efficacy and longevity of two novel approaches to changing skin protection behaviors: 1) UV-detect photos that reveal currently existing skin damage and 2) motivational interviewing (MI), a person-centered, yet directive counseling style used to enhance internal motivation to change health behaviors. The proposed investigations include a pilot study to refine the methodology; a small formal randomized controlled efficacy trial; and a dismantling study. These studies will also expand current knowledge and research in several major ways: 1) the use of UV-detect photos will enable highly salient and personalized feedback, 2) MI will be used in a previously untried health domain (skin cancer prevention), 3) objective skin color changes will be measured using state-of-the-art skin reflectance spectrophotometry, and 4) the proposed studies will test aspects of several major psychological theories (e.g., Transtheoretical Model, Prototype/Willingness Model) to identify moderators/mediators of outcome.

Condition or disease Intervention/treatment Phase
Skin Cancer Prevention Device: UV-Detect Photos Behavioral: Motivational Interviewing Behavioral: Education Not Applicable

Detailed Description:
Teens and young adults are at high risk for overexposure to ultraviolet (UV) radiation, a leading factor in the development of skin cancer. The majority of these individuals continue to protect themselves minimally and tan intentionally, including significant increases in tanning booth use recently. Such care-free behaviors exist despite widespread education/awareness about UV radiation and skin cancer. The purpose of the proposed project is to investigate the efficacy and longevity of two novel approaches to changing skin protection behaviors: 1) UV-detect photos that reveal currently existing skin damage and 2) motivational interviewing (MI), a person-centered, yet directive counseling style used to enhance internal motivation to change health behaviors. The proposed investigations include a pilot study to refine the methodology; a small formal randomized controlled efficacy trial; and a dismantling study. These studies will also expand current knowledge and research in several major ways: 1) the use of UV-detect photos will enable highly salient and personalized feedback, 2) MI will be used in a previously untried health domain (skin cancer prevention), 3) objective skin color changes will be measured using state-of-the-art skin reflectance spectrophotometry, and 4) the proposed studies will test aspects of several major psychological theories (e.g., Transtheoretical Model, Prototype/Willingness Model) to identify moderators/mediators of outcome. Therefore, the studies should provide useful information about process and outcome for skin cancer prevention researchers and clinicians.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention
Study Start Date : March 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Placebo Comparator: Education
Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
Behavioral: Education
Education

Active Comparator: Motivational Interviewing
Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
Behavioral: Motivational Interviewing
Motivational Interviewing

Active Comparator: UV-detect photos
Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that "Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage." Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average.
Device: UV-Detect Photos
UV-Detect Photos

Experimental: UV-detect photos & MI
Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
Device: UV-Detect Photos
UV-Detect Photos

Behavioral: Motivational Interviewing
Motivational Interviewing




Primary Outcome Measures :
  1. Sun Stage of Change at 3 Months [ Time Frame: 3 months ]
    The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).

  2. Sun Stage of Change at 12 Months [ Time Frame: 12 months ]
    The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 or older

Exclusion Criteria:

  • Visual impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709306


Locations
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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19012
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Carolyn Heckman, PhD Fox Chase Cancer Center

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Responsible Party: Carolyn Heckman, Associate Professor, Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00709306     History of Changes
Other Study ID Numbers: K07CA108685 ( U.S. NIH Grant/Contract )
K07CA108685 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2008    Key Record Dates
Results First Posted: February 22, 2018
Last Update Posted: August 31, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases